Ozoralizumab shows therapeutic potential in rheumatoid arthritis

Treatment with the next-generation anti-TNFα antibody yields marked improvements in the signs and symptoms of rheumatoid arthritis (RA) in patients with inadequate response to methotrexate (MTX), while having an acceptable safety profile, as shown in the phase II/III OHZORA trial.

OHZORA randomized 381 patients (mean age 55.0 years, 74.8 percent female, 89.2 percent seropositive for rheumatoid factor and/or anticitrullinated protein antibody) to receive placebo (n=75) or ozoralizumab at 30 mg (n=152) or 80 mg (n=154), administered subcutaneously every 4 weeks with MTX for 24 weeks. The mean disease duration was 7.4 years, with baseline Disease Activity Score 28 using C-reactive protein (DAS28-CRP) of 5.13 and modified total Sharp score (mTSS) of 27.46.

The primary endpoints of a 20-percent improvement rate in the American College of Rheumatology criteria (ACR20 response rate) at week 16 and no structural progression at week 24 were significantly higher in both ozoralizumab groups vs the placebo group.

Specifically, ACR20 response at week 16 was documented in 79.6 percent of patients in the 30-mg dose group, 75.3 percent in the 80-mg dose group, 37.3 percent in the placebo group. The respective proportions of patients who showed no change in mTSS at week 24 were 73.0 percent, 73.4 percent, and 56.0 percent.

Other endpoints, including DAS28-CRP and both CRP and erythrocyte sedimentation rate, showed significant improvements as early as day 3.

In terms of safety, most adverse events (AEs) were mild to moderate in severity, with infection being the most common. Serious AEs occurred in four patients in the 30-mg (pelvic fracture, diabetes mellitus, lung adenocarcinoma, and interstitial lung disease) and five patients in the 80-mg (ovarian carcinoma/uterine carcinoma, renal abscess, cerebellar haemorrhage, and interstitial lung disease) ozoralizumab groups.